DUREZOL (difluprednate - emulsion;ophthalmic)

Has a generic version of Durezol been approved?

No. There is currently no therapeutically equivalent version of Durezol available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Durezol. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Compositions containing difluprednatePatent 6,114,319Issued: September 5, 2000Inventor(s): Kimura; Masako & Yasueda; Shin-ichi & Yamaguchi; Masazumi & Inada; KatsuhiroAssignee(s): Senju Pharmaceutical Co., Ltd.
Mitsubishi Chemical CorporationThe present invention relates to a liquid composition comprising difluprednate, oil, water and an emulsifier. The composition of the present invention has superior antiinflammatory action and antiallergic action. The composition of the present invention shows superior transfer to a lesion and uniform drug distribution upon administration, as compared to conventional preparations containing difluprednate, so that it shows sufficient efficacy in a smaller dose. The inventive composition is associated with extremely less uncomfortable feeling and foreign sensation upon administration, as compared to conventional preparations containing difluprednate, and it can be administered easily to local sites of eye, nose, ear and the like.

Patent expiration dates:

May 18, 2019

✓

Drug product

November 18, 2019

✓

Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:

June 13, 2015 - TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS

December 13, 2015 -

March 22, 2016 - REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO REFLECT THE RESULTS FROM CLINICAL STUDY C-10-004

Glossary

Term

Definition

Drug Patent

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.

Drug Exclusivity

Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.

RLD

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.